K222095 is an FDA 510(k) clearance for the BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter,.... Classified as Mechanical Thrombolysis Catheter (product code QEY), Class II - Special Controls.
Submitted by Thrombolex, Inc. (New Britain, US). The FDA issued a Cleared decision on April 20, 2023 after a review of 276 days - an extended review cycle.
This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5150 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.
Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.
View all Thrombolex, Inc. devices
NCT04248868
Completed
Interventional
Industry-sponsored
tPA by Endovascular Administration for the Treatment of Submassive PE Using CDT for the Reduction of Thrombus Burden
Recombinant tPA by Endovascular Administration for the Treatment of Submassive Pulmonary Embolism Using Pharmaco-mechanical Catheter Directed Thrombolysis for the redUction of Thrombus burdEn
| Condition studied |
Pulmonary Embolism |
| Study design |
Single group |
| Eligibility |
All sexes
· 18 Years+
|
| Principal investigator |
Brian Firth, MD, PhD, MBA, FACC |
| Sponsor |
Thrombolex, Inc.
(industry)
|
Started 2020-06-23
→
Primary completion 2022-06-22
→
Completed 2022-06-23
Primary outcome
Efficacy: RV/LV Ratio Difference
View full study on ClinicalTrials.gov